BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR-POLY LINER-36MM

    MDR report key: 6332541 · Received February 15, 2017

    Report

    Report Number
    3005985723-2017-00068
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    January 24, 2017
    Report Date
    April 26, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OQG
    PMA / PMN Number
    K122158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. AN EVENT REGARDING DAMAGED THREADS INVOLVING AN IMPACTOR WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. NO PATIENT MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES THERE HAS BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 1

    A 112636 POLY LINER IMPACTOR IS CROSS THREADED AND WON'T TIGHTEN DOWN.

    Description of Event or Problem · 1

    A 112636 POLY LINER IMPACTOR IS CROSS THREADED AND WON'T TIGHTEN DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116324 IMPACTOR-POLY LINER-36MM HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS, OQG MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O